JD Supra

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...
MD&M East

How to Use Surrogate Devices for Validation of Destructive Test Methods for Combination Product Design Verification

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
RAPS

Medical Device Validation: What You Need to Know and Why It's Important

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...
RAPS

FDA officials: Consider a master validation plan for process validation during inspections

COLUMBUS, OH – Having a master validation plan in place will help inspectors identify validated and verified activities during an inspection at your company, according to US Food and Drug ...